Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients

NCT00140751 | Completed Phase 3

• 2 other identifiers: IMEA-030KALESOLO
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 25

Brief Summary

The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients

Conditions

HIV Infections

Keywords

HIV-1; Treatment simplification; Lopinavir/ritonavir; Treatment Experienced; HIV Seropositivity

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study

  W48

Secondary Outcomes (8)

• Durability of viral response

  W48

• Evolution of lymphocytes CD4

  W48

• Observance

  W48

• Clinical and biological tolerance

  W48

• Quantitative and qualitative changes in quality of life data

  W48

Study Arms (2)

Simplification

EXPERIMENTAL

The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks

Drug: Lopinavir/ritonavir (drug)

Continued

NO INTERVENTION

The patients included in this arm continue their treatment without any changes

Interventions

Lopinavir/ritonavir (drug) DRUG

Simplification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years
• Confirmed HIV-1 seropositivity
• Antiretroviral treatment stable since 3 months at least
• HIV-1 ARN load \< 50 copies/mL since 6 months at least
• Signed consent form
• No history of treatment failure (= viral load \> 1000 copies/mL) including a protease inhibitor
• No opportunistic infection in the previous 6 months

You may not qualify if:

• Neutrophils \< 750/mm3
• Hemoglobin \< 8 g/dL
• Platelets \< 60,000/mm3
• Creatinin \> 150 micromoles/L
• SGOT \> 5 NUL (Normal Upper Limit)
• SGPT \> 5 NUL
• Current IL-2 treatment
• HBV infection treated or not by lamivudine or tenofovir
• Pregnancy or feeding
• Enrollment in another study not compliant with KALESOLO Study group assignment

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• Abbott: collaborator

Study Sites (25)

Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales

Fort-de-France, Martinique, 97261, France

Location

Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie

Annecy, 74000, France

Location

Hôpital Jean Verdier - Unité de Maladies Infectieuses

Bondy, 93143, France

Location

Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

Bordeaux, 33000, France

Location

Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses

Bordeaux, 33000, France

Location

Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales

Bordeaux, 33000, France

Location

Hôpital Côte de Nacre - Service des Maladies Infectieuses

Caen, 14033, France

Location

Hôpital Henri Mondor - Service d'Immunologie Clinique

Créteil, 94010, France

Location

Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales

Garches, 92380, France

Location

Hôpital A. Michallon - Service des Maladies Infectieuses

Grenoble, 38000, France

Location

Hôpital Bicêtre - Service de Médecine Interne

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Nord - CISIH

Marseille, 13020, France

Location

Hôpital Sainte-Marguerite - Unité Médicale CISIH

Marseille, 13274, France

Location

Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

Montpellier, 34000, France

Location

Hôpital de l'Archet - Service d'Infectiologie

Nice, 06200, France

Location

Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales

Paris, 75012, France

Location

Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales

Paris, 75013, France

Location

Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1

Paris, 75013, France

Location

Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie

Paris, 75015, France

Location

Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

Paris, 75020, France

Location

Hôpital Pontchaillou - Service des Maladies Infectieuses

Rennes, 35000, France

Location

Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A

Strasbourg, 67000, France

Location

Hôpital Gustave Dron - Service des Maladies Infectieuses

Tourcoing, 59200, France

Location

Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (11)

• Mocroft A, Ledergerber B, Katlama C, Kirk O, Reiss P, d'Arminio Monforte A, Knysz B, Dietrich M, Phillips AN, Lundgren JD; EuroSIDA study group. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet. 2003 Jul 5;362(9377):22-9. doi: 10.1016/s0140-6736(03)13802-0.

  PMID: 12853195 BACKGROUND

• Yeni PG, Hammer SM, Hirsch MS, Saag MS, Schechter M, Carpenter CC, Fischl MA, Gatell JM, Gazzard BG, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Schooley RT, Thompson MA, Vella S, Volberding PA. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA. 2004 Jul 14;292(2):251-65. doi: 10.1001/jama.292.2.251.

  PMID: 15249575 BACKGROUND

• Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77. doi: 10.1097/00002030-200107270-00006.

  PMID: 11504958 BACKGROUND

• Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.

  PMID: 9516219 BACKGROUND

• Murphy R, Gazzard B. Antiretroviral treatment guidelines. AIDS. 2003 Jun;17 Suppl 2:S1. doi: 10.1097/00002030-200306002-00001. No abstract available.

  PMID: 12870522 BACKGROUND

• Bucher HC, Kofler A, Nuesch R, Young J, Battegay M, Opravil M. Meta-analysis of randomized controlled trials of simplified versus continued protease inhibitor-based antiretroviral therapy in HIV-1-infected patients. AIDS. 2003 Nov 21;17(17):2451-9. doi: 10.1097/00002030-200311210-00007.

  PMID: 14600516 BACKGROUND

• Drechsler H, Powderly WG. Switching effective antiretroviral therapy: a review. Clin Infect Dis. 2002 Nov 15;35(10):1219-30. doi: 10.1086/343050. Epub 2002 Oct 21.

  PMID: 12410482 BACKGROUND

• Martinez E, Conget I, Lozano L, Casamitjana R, Gatell JM. Reversion of metabolic abnormalities after switching from HIV-1 protease inhibitors to nevirapine. AIDS. 1999 May 7;13(7):805-10. doi: 10.1097/00002030-199905070-00009.

  PMID: 10357379 BACKGROUND

• Moyle G, Baldwin C, Mandalia S, Comitis S, Burn P, Gazzard B. Changes in metabolic parameters and body shape after replacement of protease inhibitor With efavirenz in virologically controlled HIV-1-positive persons: single-arm observational cohort. J Acquir Immune Defic Syndr. 2001 Dec 1;28(4):399-401. doi: 10.1097/00126334-200112010-00016. No abstract available.

  PMID: 11707680 BACKGROUND

• Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

  PMID: 29767684 DERIVED

• Meynard JL, Bouteloup V, Landman R, Bonnard P, Baillat V, Cabie A, Kolta S, Izopet J, Taburet AM, Mercie P, Chene G, Girard PM; KALESOLO Study Group. Lopinavir/ritonavir monotherapy versus current treatment continuation for maintenance therapy of HIV-1 infection: the KALESOLO trial. J Antimicrob Chemother. 2010 Nov;65(11):2436-44. doi: 10.1093/jac/dkq327. Epub 2010 Sep 15.

  PMID: 20843990 DERIVED

Related Links

• Click here for more information about this study: KALESOLO

MeSH Terms

Conditions

HIV Infections; HIV Seropositivity

Interventions

Lopinavir; Ritonavir; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Jean-Luc MEYNARD, MD, PhD

  Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales (Paris, France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: October 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

FR (25)